Back to resultsFunctional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
Primary Purpose
Constipation
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring constipation, gastric emptying
Eligibility Criteria
Inclusion Criteria:
- Age 18-80
- constipation defined by the Rome II criteria
Exclusion Criteria:
- Past history of abdominal surgery
- past history of diabetes mellitus
- past history of hypothyroidism
- past history of inflammatory bowel disease
- past history of significant psychiatric disturbances
- past history of drug abuse
- past history of cardiac pacemakers
- past history of metal implants
- patients who cannot travel to keep the follow up
- patients who are prisoners
- patients who are mentally handicapped
- patients who are pregnant
Sites / Locations
- Cleveland Clinic Digestive Disease Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment
Sham
Arm Description
FMS will be administered for 5 weeks
FMS at 5% intensity for 5 weeks
Outcomes
Primary Outcome Measures
Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol
Secondary Outcome Measures
Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period
Full Information
NCT ID
NCT01786837
First Posted
February 6, 2013
Last Updated
February 2, 2016
Sponsor
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01786837
Brief Title
Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
Official Title
A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.
Detailed Description
The goal of this pilot study is to evaluate the usefulness of FMS as a noninvasive method to stimulate the GI motility in individuals with non-neurological constipation by adopting a 5-week conditioning protocol performed in a hospital outpatient setting. FMS has demonstrated the ability to generate significant rectal pressure and enhance GI transit in normal and spinal cord injury subjects. With proper abdominal muscle conditioning, FMS may improve colonic motility partly due to improved abdominal muscle tone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, gastric emptying
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
FMS will be administered for 5 weeks
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
FMS at 5% intensity for 5 weeks
Intervention Type
Device
Intervention Name(s)
Functional Magnetic Stimulation
Other Intervention Name(s)
Commericially available magnetic stimulations with round magnetic coils.
Intervention Description
20 minute stimulation will be applied 5 days a week for 5 weeks
Primary Outcome Measure Information:
Title
Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol
Time Frame
5 weeks after conditioning
Secondary Outcome Measure Information:
Title
Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period
Time Frame
5 weeks after conditioning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-80
constipation defined by the Rome II criteria
Exclusion Criteria:
Past history of abdominal surgery
past history of diabetes mellitus
past history of hypothyroidism
past history of inflammatory bowel disease
past history of significant psychiatric disturbances
past history of drug abuse
past history of cardiac pacemakers
past history of metal implants
patients who cannot travel to keep the follow up
patients who are prisoners
patients who are mentally handicapped
patients who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massarat Zutshi, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Digestive Disease Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
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